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Product NDC Code | 70677-0067 | ||||
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Drug Name | Sunmark regular strength antacid peppermint |
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Type | Brand | ||||
Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET, CHEWABLE | ||||
RxCUI drug identifier | 308907 | ||||
Application Number | part331 | ||||
Labeler Name | Strategic Sourcing Services LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT (in each tablet) Calcium carbonate 500 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS adults and children 12 years of age and over: wet in mouth before chewing chew 2-4 tablets as symptoms occur, or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS corn starch, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, sucrose, talc.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USE(S) relieves: acid indigestion heartburn
Purpose
Information about the drug product’s indications for use.PURPOSE Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Sunmark Regular Strength Antacid Peppermint Calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION STARCH, CORN DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN SUCROSE TALC CROSPOVIDONE G113
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL sunmark COMPARE TO TUMS® ACTIVE INGREDIENT* NDC 70677-0067-1 antacid tablets Regular Strength Calcium Carbonate 500 mg Fast relief of heartburn & acid indigestion PEPPERMINT 150 CHEWABLE TABLETS 113-Sunmark-150ct
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN .
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT do not take more than 15 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.
Pregnancy or breast feeding
Pregnancy or Breast feedingIF PREGNANT OR BREAST FEEDING, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION each tablet contains: elemental calcium 200 mg do not use if printed seal under the cap is torn or missing. store below 30˚C (86˚F). keep the container tightly closed.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS .
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API